The objective of this study is to determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dose interval.

The secondary objective is to determine the extend of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval, to determine the area under the concentration time curve of raltegravir in semen, and to determine the variability in the penetration of raltegravir into the seminal compartment over the dosing period.

Single group study of seminal plasma pharmacokinetics of raltegravir in men receiving chronic raltegravir therapy

Other: Seminal plasma pharmacokinetics

Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.

Detailed Description:

The patient population will consist of 12 male HIV-positive patients who have been receiving stable antiretroviral therapy that includes raltegravir for a minimum of three months. Patients will be enrolled from one clinic in downtown Toronto and a hospital affiliated HIV specialty clinic in Ottawa, Ontario. Eligible patients will have evidence of full virologic suppression (HIV viral load < 50 copies/mL) at least one month prior to enrollment in the study. No changes will be made to the patients antiretroviral therapy during the course of the study.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

12 HIV-positive males

Criteria

Inclusion Criteria:

HIV infected male

18 years old or older

on raltegravir twice daily as part of their antiretroviral regimen for at least 3 months prior to screening

viral load < 50 copies/mL at least one month prior to enrolling

able to read, understand and sign a written informed consent prior to initiation of the study

medically stable at the time of the study, with no evidence of acute illness

Exclusion Criteria:

having difficulty adhering to current antiretroviral therapy

patient is expected to have difficulties adhering with study protocol

patients with malignancy, or acute renal or liver disease

patient with active AIDS-defining illness

patient with any medical, psychiatric or other circumstance that may impede the provision of informed consent

patient with any of the following abnormalities at the time of screening:

patient receiving concomitant therapy with rifampin or St. John's wort

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045265